MAUDE MDR 9392303
- MDR report key
- 9392303
- Report number
- 1627487-2019-13360
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-11-12
- Date received
- 2019-11-30
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- ANDREA DEITZ
- Address
- 6901 PRESTON ROAD PLANO TX 75024 US
- Phone
- 972-972-9723
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | DRG IPG | ST. JUDE MEDICAL - NEUROMODULATION | PMP | 3664 | 3664 | 6145091 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-11-30 | 0 | 1. O |
Event Narratives#
No narrative records found.